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Following cases of six serious adverse reactions nationwide to the Johnson & Johnson COVID-19 vaccine, including one death, the N.C. Department of Health and Human Services recommended Tuesday that providers pause administration of the doses “out of an abundance of caution.”
The incidences were “literally one in a million,” said DHHS Secretary Dr. Mandy Cohen, who received the Johnson & Johnson vaccine.
The move comes as the national Centers for Disease Control and Prevention and the Food and Drug Administration recommended pausing the Johnson & Johnson vaccine nationwide. None of the adverse responses, reported through the Vaccine Adverse Event Reporting System, took place in North Carolina.
“Today’s announcement shows that we have a robust safety system in place and that that system is working to identify any concerns,” Cohen said Tuesday. The Moderna and Pfizer vaccines remain safe and effective, according to Cohen.
Those who received the J&J vaccine in the last three weeks and experienced severe headache, abdominal pain, leg pain or shortness of breath after day three should contact their health care provider.
Flu-like symptoms in the first few days after vaccination are common and not serious, Dr. Peter Marks, FDA Center for Biologics Evaluation and Research director, said Tuesday.
The extremely rare type of clot in conjunction with low platelets occurred in women between the ages of 18 and 48 who experienced symptoms six to 13 days after receiving the dose. Typically, a blood-thinning medication such as heparin is used to treat clots, but this reaction requires a different treatment, Cohen said.
While other drugs, such as oral contraceptives, create blood clots at higher rates than the vaccine, “this is a very different and rare type of clot” that requires an alternative treatment, Cohen said.
The department advised health care providers to be aware of the different symptoms of a response and to inquire about vaccination should patients exhibit these symptoms.
Nearly a quarter of a million doses of the Johnson & Johnson vaccine have been administered in the state. The recommendation of the department is not a mandate, Cohen said, and providers may continue to provide doses.
Providers that halt the use of Johnson & Johnson may elect to either reschedule recipients’ appointments or schedule substitutions of the Pfizer or Moderna shot. The state has approximately 85,000 doses of Pfizer and Moderna vaccines available, with additional doses arriving this week, said Amanda Fuller Moore, DHHS Division of Public Health pharmacist.
Some vaccine seekers preferred the one-dose Johnson & Johnson vaccine over the two-dose Pfizer and Moderna shots. The Johnson & Johnson shot also required less complicated storage and shipment.
Cohen encouraged North Carolinians not to be deterred by the pause and reiterated the safety of the vaccine and its importance in fighting the pandemic.
“We know these vaccines are safe,” she said. “They are effective at preventing COVID. They are effective at making sure you’re not getting into the hospital, that you are not dying from this virus.”
The CDC Advisory Committee on Immunization Practices meets Wednesday to review the issue and consider future action. The FDA is also conducting a review.